Collins, Kenneth A. (Mission Viejo, CA, US)

11/068954

09/16/2008

03/01/2005

Download PDF 7425216       PDF help

Click for automatic bibliography generation

Alsius Corporation (Irvine, CA, US)

607/105

607/104, 607/106

A61F7/12

607/96, 607/104-114

6019783	Cooling system for therapeutic catheter	February, 2000	Philips	607/105
6042559	Insulated catheter for selective organ perfusion	March, 2000	Dobak	604/7
6096068	Selective organ cooling catheter and method of using the same	August, 2000	Dobak	607/105
6110168	Method and apparatus for controlling a patient's body temperature by in situ blood temperature modifications	August, 2000	Ginsburg	606/27
6126684	Indwelling heat exchange catheter and method of using same	October, 2000	Gobin	607/113
6146411	Cooling system for indwelling heat exchange catheter	November, 2000	Noda	607/105
6149670	Method and system for treating cardiac arrest using hypothermia	November, 2000	Worthen	607/3
6149673	Method for controlling a patient's body temperature by in situ blood temperature modification	November, 2000	Ginsburg	607/96
6149676	Catheter system for controlling a patient's body temperature by in situ blood temperature modification	November, 2000	Ginsburg	607/106
6149677	Circulating fluid hypothermia method	November, 2000	Dobak	607/106
6165207	Method of selectively shaping hollow fibers of heat exchange catheter	December, 2000	Balding	607/105
6224624	Selective organ cooling apparatus and method	May, 2001	Lasheras	607/105
6231594	Method of controlling body temperature while reducing shivering	May, 2001	Dae	607/96
6231595	Circulating fluid hypothermia method and apparatus	May, 2001	Dodak	607/106
6235048	Selective organ hypothermia method and apparatus	May, 2001	Dobak	607/104
6238428	Selective organ cooling apparatus and method employing turbulence-inducing element with curved terminations	May, 2001	Werneth	607/105
6245095	Method and apparatus for location and temperature specific drug action such as thrombolysis	June, 2001	Dobak	607/105
6251129	Method for low temperature thrombolysis and low temperature thrombolytic agent with selective organ temperature control	June, 2001	Dobak	607/105
6251130	Device for applications of selective organ cooling	June, 2001	Dobak	607/105
6254626	Articulation device for selective organ cooling apparatus	July, 2001	Dobak	607/105
6264679	Heat exchange catheter with discrete heat exchange elements	July, 2001	Keller	607/105
6287326	Catheter with coiled multi-lumen heat transfer extension	September, 2001	Pecor	607/105
6290717	Temperature probe and interconnect cable for hypothermia catheter temperature feedback	September, 2001	Philips	607/113
6299599	Dual balloon central venous line catheter temperature control system	October, 2001	Pham	604/113
6306161	Catheter system for controlling a patient's body temperature by in situ blood temperature modification	October, 2001	Ginsburg	607/106
6312452	Selective organ cooling catheter with guidewire apparatus and temperature-monitoring device	November, 2001	Dobak	607/105
6325818	Inflatable cooling apparatus for selective organ hypothermia	December, 2001	Werneth	607/105
6338727	Indwelling heat exchange catheter and method of using same	January, 2002	Noda	604/113
6364899	Heat pipe nerve cooler	April, 2002	Dobak	607/113
6368304	Central venous catheter with heat exchange membrane	April, 2002	Aliberto	604/113
6379378	Lumen design for catheter	April, 2002	Werneth	607/96
6383210	Method for determining the effective thermal mass of a body or organ using cooling catheter	May, 2002	Magers et al.	607/105
6393320	Method for treating cardiac arrest	May, 2002	Lasersohn	607/3
6405080	Method and system for treating cardiac arrest	June, 2002	Lasersohn	607/3
6409747	Indwelling heat exchange catheter and method of using same	June, 2002	Gobin	607/113
6416533	Indwelling heat exchange catheter and method of using same	July, 2002	Gobin	607/113
6419643	Central venous catheter with heat exchange properties	July, 2002	Shimada	600/323
6428563	Heat exchange catheter with improved insulated region	August, 2002	Keller	607/105
6432124	Method and system treating heart malady such as cardiac arrest and heart attack using hypothermia	August, 2002	Worthen	607/105
6436130	Cooling system for therapeutic catheter	August, 2002	Philips	607/105
6436131	Heat exchange catheter having heat exchange surface formed of metal foil	August, 2002	Ginsburg	607/106
6440158	Heat transfer catheter apparatus and method of making and using same	August, 2002	Saab	604/105
6447474	Automatic fever abatement system	September, 2002	Balding	604/66
6450987	Collapsible guidewire lumen	September, 2002	Kramer	604/523
6450990	Catheter with multiple heating/cooling fibers employing fiber spreading features	September, 2002	Walker	604/113
6451045	Heat exchange catheter having a helically wrapped heat exchanger	September, 2002	Walker	607/105
6454792	Cooling system for indwelling heat exchange catheter	September, 2002	Noda et al.	607/105
6454793	Method and apparatus for establishing and maintaining therapeutic hypothermia	September, 2002	Evans	607/105
6458150	Method and apparatus for patient temperature control	October, 2002	Evans	607/105
6460544	Method and apparatus for establishing and maintaining therapeutic hypothemia	October, 2002	Worthen	607/105
6464716	Selective organ cooling apparatus and method	October, 2002	Dobak	607/105
6468296	Method for low temperature thrombolysis and low temperature thrombolytic agent with selective organ temperature control	October, 2002	Dobak	607/105
6471717	Selective organ cooling apparatus and method	October, 2002	Dobak	607/105
6475231	Method and device for applications of selective organ cooling	November, 2002	Dobak	607/105
6478811	Method for low temperature thrombolysis and low temperature thrombolytic agent with selective organ temperature control	November, 2002	Dobak	607/105
6478812	Method and device for applications of selective organ cooling	November, 2002	Dobak	607/105
6482226	Selective organ hypothermia method and apparatus	November, 2002	Dobak	607/104
6491039	Medical procedure	December, 2002	Dobak	128/898
6491716	Method and device for applications of selective organ cooling	December, 2002	Dobak	607/105
6494903	Over the wire heat exchange catheter with distal valve	December, 2002	Pecor	607/105
6497721	Method and apparatus for regional and whole body temperature modification	December, 2002	Ginsburg	607/106
6516224	Method for treating cardiac arrest	February, 2003	Lasersohn	607/3
6520933	Central venous line cooling catheter having a spiral-shaped heat exchange member	February, 2003	Evans	604/103.07
6527798	Method and apparatus for regional and whole body temperature modification	March, 2003	Ginsburg	607/106
6529775	System and method employing indwelling RF catheter for systemic patient warming by application of dielectric heating	March, 2003	Whitebook	607/100
6530946	Indwelling heat exchange heat pipe catheter and method of using same	March, 2003	Noda	607/113
6533804	Inflatable catheter for selective organ heating and cooling and method of using the same	March, 2003	Dobak	607/105
6540771	Inflatable catheter for selective organ heating and cooling and method of using the same	April, 2003	Dobak	607/105
6544282	Inhibition of platelet activation, aggregation and/or adhesion by hypothermia	April, 2003	Dae	607/105
6551349	Selective organ cooling apparatus	April, 2003	Lasheras	607/105
6554797	Method and system for patient temperature management and central venous access	April, 2003	Worthen	604/113
6558412	Selective organ hypothermia method and apparatus	May, 2003	Dobak	607/105
6572538	Flexible endoscope	June, 2003	Takase	600/140
6572638	Method of controlling body temperature while inhibiting thermoregulatory responses	June, 2003	Dae et al.	607/96
6572640	Method and apparatus for cardiopulmonary bypass patient temperature control	June, 2003	Balding	607/105
6576001	Lumen design for catheter	June, 2003	Werneth	607/96
6576002	Isolated selective organ cooling method and apparatus	June, 2003	Dobak	607/105
6581403	Heating/cooling system for indwelling heat exchange catheter	June, 2003	Whitebook	62/434
6582398	Method of managing patient temperature with a heat exchange catheter	June, 2003	Worthen	604/113
6582455	Method and device for applications of selective organ cooling	June, 2003	Dobak	607/105
6582457	Method of controlling body temperature while reducing shivering	June, 2003	Dae	607/113
6585692	Method and system for patient temperature management and central venous access	July, 2003	Worthen	604/113
6585752	Fever regulation method and apparatus	July, 2003	Dobak	607/105
6589271	Indwelling heat exchange catheter	July, 2003	Tzeng	607/113
6595967	Collapsible guidewire lumen	July, 2003	Kramer	604/523
6599312	Isolated selective organ cooling apparatus	July, 2003	Dobak	607/105
6602243	Foley catheter having redundant temperature sensors and method	August, 2003	Noda	604/544
6602276	Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation	August, 2003	Dobak	607/105
6607517	Method of inotropic treatment of heart disease using hypothermia	August, 2003	Dae	604/31
6610083	Multiple lumen heat exchange catheters	August, 2003	Keller	607/105
6620130	Infusion systems and methods for introducing fluids into the body within a desired temperature range	September, 2003	Ginsburg	604/113
6620131	Dual balloon central venous line catheter temperature control system	September, 2003	Pham	604/113
6620188	Methods and apparatus for regional and whole body temperature modification	September, 2003	Ginsburg	607/106
6620189	Method and system for control of a patient's body temperature by way of a transluminally insertable heat exchange catheter	September, 2003	MacHold	607/106
6623516	Method for changing the temperature of a selected body region	September, 2003	Saab	607/105
6635076	System for controlling body temperature of a patient	October, 2003	Ginsburg	607/106
6641602	Method and device including a colo-rectal heat exchanger	November, 2003	Balding	607/105
6641603	Heat exchange catheter having helically wound reinforcement	November, 2003	Walker	607/105
6645234	Cardiovascular guiding catheter with heat exchange properties and methods of use	November, 2003	Evans	607/113
6648906	Method and apparatus for regulating patient temperature by irrigating the bladder with a fluid	November, 2003	Lasheras	607/105
6648908	Inflatable catheter for selective organ heating and cooling and method of using the same	November, 2003	Dobak	607/105
6652565	Central venous catheter with heat exchange properties	November, 2003	Shimada	607/113
6656209	Catheter system for controlling a patient's body temperature by in situ blood temperature modification	December, 2003	Ginsburg	607/106
6660028	Method for determining the effective thermal mass of a body or organ using a cooling catheter	December, 2003	Magers	607/105
6673098	Disposable cassette for intravascular heat exchange catheter	January, 2004	MacHold	607/106
6676688	Method of making selective organ cooling catheter	January, 2004	Dobak	607/105
6676689	Inflatable catheter for selective organ heating and cooling and method of using the same	January, 2004	Dobak	607/105
6676690	Inflatable heat transfer apparatus	January, 2004	Werneth	607/105
6679906	Catheter system with on-board temperature probe	January, 2004	Hammack	607/105
6679907	Method and device for applications of selective organ cooling	January, 2004	Dobak	607/105
6682551	Method and system for treating cardiac arrest using hypothermia	January, 2004	Worthen	607/105
6685732	METHOD AND DEVICE FOR PERFORMING COOLING- OR CRYO-THERAPIES FOR, E.G., ANGIOPLASTY WITH REDUCED RESTENOSIS OR PULMONARY VEIN CELL NECROSIS TO INHIBIT ATRIAL FIBRILLATION EMPLOYING MICROPOROUS BALLOON	February, 2004	Kramer	607/106
6685733	Methods and systems for reducing substance-induced renal damage	February, 2004	Dae	607/105
6692488	Apparatus for cell necrosis	February, 2004	Dobak	606/21
6692519	Use of endovascular hypothermia in organ and/or tissue transplantations	February, 2004	Hayes	607/105
6695873	Inflatable catheter for selective organ heating and cooling and method of using the same	February, 2004	Dobak	607/105
6695874	Method and system for control of a patient's body temperature by way of transluminally insertable heat exchange catheter	February, 2004	MacHold	607/106
6699268	Radio frequency patient heating system	March, 2004	Kordis	607/113
6702783	Endovascular heat-and gas-exchange catheter device and related methods	March, 2004	Dae	604/113
6702839	Method of controlling body temperature while reducing shivering	March, 2004	Dae	607/96
6702840	Heat exchange catheter with discrete heat exchange elements	March, 2004	Keller	607/105
6702841	Method of manufacturing a heat transfer element for in vivo cooling	March, 2004	Nest	607/105
6702842	Selective organ cooling apparatus and method	March, 2004	Dobak	607/105
6706060	Heat exchange catheter	March, 2004	Tzeng	607/105
6709448	Open core heat exchange catheter, system and method	March, 2004	Walker	607/105
6716188	Indwelling heat exchange catheter and method of using same	April, 2004	Noda	604/6.13
6716236	Intravascular catheter with heat exchange element having inner inflation element and methods of use	April, 2004	Tzeng	607/113
6719723	Multipurpose catheter assembly	April, 2004	Werneth	604/113
6719724	Central venous line catheter having multiple heat exchange elements and multiple infusion lumens	April, 2004	Walker	604/113
6719779	Circulation set for temperature-controlled catheter and method of using the same	April, 2004	Daoud	607/105
6726653	Indwelling heat exchange catheter and method of using same	April, 2004	Noda	604/113
6726708	Therapeutic heating and cooling via temperature management of a colon-inserted balloon	April, 2004	Lasheras	607/105
6726710	Method and system for treating cardiac arrest using hypothermia	April, 2004	Worthen	607/105
6733517	Angling introducer sheath for catheter having temperature control system	May, 2004	Collins	607/105
6740109	Isolated selective organ cooling method	May, 2004	Dobak	607/105
6749585	Central venous catheter with heat exchange membrane	June, 2004	Aliberto	604/113
6749625	Intravascular temperature control catheter	June, 2004	Pompa	607/105
6752786	Moving heat exchange catheter system	June, 2004	Callister	604/113
6755850	Selective organ hypothermia method and apparatus	June, 2004	Dobak	607/104
6755851	Indwelling heat exchange catheter and method of using same	June, 2004	Noda	607/113
20010007951	Circulating fluid hypothermia method and apparatus	July, 2001	Dobak	607/106
20010016764	Selective organ hypothermia method and apparatus	August, 2001	Dobak, III	607/105
20010041923	Patient temperature regulation method and apparatus	November, 2001	Dobak	607/105
20020007203	Method of manufacturing a heat transfer element for in vivo cooling	January, 2002	Gilmartin	607/105
20020016621	Lumen design for catheter	February, 2002	Werneth	607/96
20020068964	Heat pipe nerve cooler	June, 2002	Dobak	607/113
20020077680	Temperature sensor adapter for foley catheters	June, 2002	Noda	600/549
20020091429	Method and device for applications of selective organ cooling	July, 2002	Dobak	607/105
20020111616	Method for reducing myocardial infarct by application of intravascular hypothermia	August, 2002	Dea	606/27
20020151946	Patient temperature regulation method and apparatus	October, 2002	Dobak, III	607/105
20020177804	Heat transfer catcheters methods of making and using same	November, 2002	Saab	607/105
20020183692	Heat transfer catheter with elastic fluid lumens	December, 2002	Callister	604/113
20020193738	Heat exchange catheter and the employment thereof	December, 2002	Adzich	604/113
20020193853	Method and system for treating cardiac arrest using hypothermia	December, 2002	Worthen	607/3
20020193854	Selective organ cooling catheter with guidewire apparatus and temperature-monitoring device	December, 2002	Dobak	607/105
20030078641	Selective organ hypothermia method and apparatus	April, 2003	Dobak	607/105
20030114835	Temperature sensor adapter for Foley catheters	June, 2003	Noda	604/544
20030144714	Selective organ hypothermia method and apparatus	July, 2003	Dobak	607/104
20030187489	Fever regulation method and apparatus	October, 2003	Dobak	607/105
20030195465	Method and system for patient temperature management and central venous access	October, 2003	Worthen	604/113
20030195466	Dual balloon central venous line catheter temperature control system	October, 2003	Pham	604/113
20030195597	Multiple lumen heat exchange catheters	October, 2003	Keller	607/105
20030216799	Method and system for treating ischemia using hypothermia	November, 2003	Worthen	606/27
20030225336	Devices and methods for measuring blood flow rate or cardiac output and for heating or cooling the body	December, 2003	Callister	600/505
20040034399	Method and apparatus for controlling a patient's body temperature in situ blood temperature modification	February, 2004	Ginsburg	607/106
20040039431	Method and system for control of a patient's body temperature by way of transluminally insertable heat exchange catheter	February, 2004	Machold
20040044388	Intravascular temperature control catheter	March, 2004	Pham	607/105
20040050154	Method and system for control of a patient's body temperature by way of transluminally insertable heat exchange catheter	March, 2004	Machold
20040054325	Infusion systems and methods for introducing fluids into the body within a desired temperature range	March, 2004	Ginsburg	604/113
20040073280	Method of controlling body temperature while reducing shivering	April, 2004	Dae
20040087934	Method and device for performing cooling- or cryo-therapies for, E.G., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation	May, 2004	Dobak
20040102825	Circulation set for temperature-controlled catheter and method of using the same	May, 2004	Daound
20040102826	Method and apparatus for regulating patient temperature by irrigating the bladder with a fluid	May, 2004	Lasheras
20040102827	Inflatable heat transfer apparatus	May, 2004	Werneth
20040106969	Inflatable catheter for selective organ heating and cooling and method of using the same	June, 2004	Dobak
20040111138	Valved connector assembly and sterility barriers for heat exchange catheters and other closed loop catheters	June, 2004	Bleam	607/105
20040116987	Method for determining the effective thermal mass of a body or organ using a cooling catheter	June, 2004	Magers
20040116988	Catheter system with on-board temperature probe	June, 2004	Hammack
20040127851	System and method for controlling rate of heat exchange with patient	July, 2004	Noda	604/503
20040133256	Heat transfer catheter with elastic fluid lumens	July, 2004	Callister	607/105
20040267339	System and method for inducing hypothermia with active patient temperature control employing catheter-mounted temperature sensor and temperature projection algorithm	December, 2004	Yon et al.
20050065583	Active body cooling with vasodilation to reduce body temperature	March, 2005	Voorhees et al.	607/104

Gibson, Roy D.

Rogitz, John L.

We claim:

1. A system for treating a patient, comprising: a heat exchange catheter configured for placement in the patient to induce hypothermia in the patient when heat exchange fluid is circulated through the catheter, the heat exchange fluid not entering the bloodstream of the patient; and a source of magnesium sulfate engageable with the patient to provide magnesium sulfate thereto through an infusion lumen of the catheter for treatment of cardiac arrest or myocardial infarction, wherein a distal portion of the catheter includes: at least first and second elongated segments, each segment having an irregular exterior surface; and a flexible articulating joint connecting the first and second elongated segments.

2. A method for treating a cardiac arrest patient, comprising: inducing hypothermia in the patient using a closed loop heat exchange catheter placed in a vein of the patient by circulating heat exchange fluid through the catheter without allowing the fluid to enter the blood; and infusing magnesium sulfate through the catheter into the patient, wherein the catheter includes: at least first and second elongated segments, each segment having an irregular exterior surface; and a flexible articulating joint connecting the first and second elongated segments.

3. The method of claim 2, wherein the catheter includes at least one balloon.

4. The method of claim 2, wherein the catheter includes plural heat exchange fluid return tubes communicating with a supply lumen at a distal end of the catheter for carrying heat exchange fluid, each return tube being formed spirally.

5. A system for treating a patient, comprising: heat exchange catheter means configured for engagement with the patient to exchange heat therewith; and magnesium sulfate infusion means defined by the catheter means for infusing extra magnesium sulfate to the patient, wherein the heat exchange means includes: at least first and second elongated segments, each segment having an irregular exterior surface; and a flexible articulating joint connecting the first and second elongated segments.

6. The system of claim 5, wherein the heat exchange means includes at least one balloon.

7. The system of claim 5, wherein the heat exchange means includes plural heat exchange fluid return tubes communicating with a supply lumen at a distal end of the heat exchange means for carrying heat exchange fluid, each return tube being formed spirally.

FIELD OF THE INVENTION

The present invention relates generally to systems for treating cardiac arrest and myocardial infarction.

BACKGROUND OF THE INVENTION

Intravascular catheters have been introduced for controlling patient temperature. Typically, a coolant such as saline is circulated through an intravascular heat exchange catheter, which is positioned in the patient's bloodstream, to cool or heat the blood as appropriate for the patient's condition. The coolant is warmed or cooled by a computer-controlled heat exchanger that is external to the patient and that is in fluid communication with the catheter.

For example, intravascular heat exchange catheters can be used to combat potentially harmful fever in patients suffering from neurological and cardiac conditions such as stroke, subarachnoid hemorrhage, intracerebral hemorrhage, cardiac arrest, and acute myocardial infarction, or to induce therapeutic hypothermia in such patients. Further, such catheters can be used to rewarm patients after, e.g., cardiac surgery or for other reasons. Intravascular catheters afford advantages over external methods of cooling and warming, including more precise temperature control and more convenience on the part of medical personnel.

The following U.S. patents, all of which are incorporated herein by reference, disclose various intravascular catheters/systems/methods: U.S. Pat. Nos. 6,419,643, 6,416,533, 6,409,747, 6,405,080, 6,393,320, 6,368,304, 6,338,727, 6,299,599, 6,290,717, 6,287,326, 6,165,207, 6,149,670, 6,146,411, 6,126,684, 6,306,161, 6,264,679, 6,231,594, 6,149,676, 6,149,673, 6,110,168, 5,989,238, 5,879,329, 5,837,003, 6,383,210, 6,379,378, 6,364,899, 6,325,818, 6,312,452, 6,261,312, 6,254,626, 6,251,130, 6,251,129, 6,245,095, 6,238,428, 6,235,048, 6,231,595, 6,224,624, 6,149,677, 6,096,068, 6,042,559.

As critically recognized by the present invention, the provision of magnesium sulfate in combination with hypothermia can effectively treat cardiac arrest and AMI.

SUMMARY OF THE INVENTION

A system for treating a patient includes a heat exchanger to induce hypothermia in the patient. The heat exchanger may be an external heat exchange pad or a heat exchange catheter configured for placement in a patient when heat exchange fluid is circulated through the catheter. A heat exchange controller supplies heat exchange fluid to the catheter and receives heat exchange fluid from the catheter in a closed circuit. A source of magnesium sulfate is used to deliver magnesium sulfate to the patient.

In one embodiment, the catheter has a heat exchange portion that is established by a balloon. In other embodiments, the heat exchange portion includes plural heat exchange fluid return tubes communicating with a supply lumen at a distal end of the catheter for carrying heat exchange fluid, with each return tube being formed spirally. In yet another embodiment, the heat exchange portion includes first and second elongated segments, each segment having an irregular exterior surface, and a flexible articulating joint connecting the first and second elongated segments.

In another aspect, a method for treating a patient includes inducing hypothermia in the patient using a closed loop heat exchange catheter, and simultaneously infusing magnesium sulfate to the patient.

In still another aspect, a system for treating a patient includes closed circuit heat exchange means and magnesium sulfate infusion means.

The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the present heat exchange catheter, schematically showing a medicament source and heat exchange fluid source in an exploded relationship with the catheter;

FIG. 2 is a perspective view of an alternate catheter;

FIG. 3 is a perspective view of another alternate catheter, showing the distal portion of the catheter and an enlarged view of the heat exchange region; and

FIG. 4 is a schematic view of an alternate embodiment using heat exchange pads.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring initially to FIG. 1, a therapeutic catheter system, generally designated 10 , is shown for establishing and maintaining hypothermia in a patient 11 , or for attenuating a fever spike in a patient 11 and then maintaining normal body temperature in the patient. While FIG. 1 shows an exemplary embodiment of one heat exchange catheter, it is to be understood that the present invention applies to any of the catheters and accompanying heat exchange controllers disclosed in the above-referenced patents, including the helical shaped devices disclosed in Alsius' U.S. Pat. Nos. 6,451,045 and 6,520,933. Also, one of the spiral-shaped or convoluted-shaped catheters disclosed in Alsius' co-pending U.S. patent application Ser. No. 10/234,084, filed Aug. 30, 2002, for an “INTRAVASCULAR TEMPERATURE CONTROL CATHETER”, and in Ser. No. 10/355,776, filed Jan. 31, 2003, both of which are incorporated herein by reference, can be used.

Commencing the description of the system 10 at the proximal end, as shown the exemplary non-limiting system 10 includes a heat exchange fluid source 12 that can be a water-bath heat exchange system or a TEC-based heat exchange system such as any of the systems disclosed in one or more of the above-referenced patents. Or, the source 12 can be a source of compressed gas. In any case, the heat exchange fluid source provides warmed or cooled heat exchange fluid such as saline or compressed gas through a heat exchange fluid supply line 14 , and heat exchange fluid is returned to the source 12 via a heat exchange fluid return line 16 . A catheter, generally designated 18 , includes a source tube 20 terminating in a fitting such as a female Luer fitting 22 . Also, the catheter 18 has a return tube 24 terminating in a fitting such a male Luer fitting 26 . The fittings 22 , 26 can be selectively engaged with complementary fittings 28 , 30 of the lines 14 , 16 to establish a closed circuit heat exchange fluid path between the catheter 18 and heat exchange fluid source 12 .

Additionally, a non-limiting catheter 18 may include a guide wire and primary infusion tube 32 that terminates in a fitting such as a female Luer 34 . A guide wire 36 can be advanced through the tube 32 in accordance with central venous catheter placement principles, or medicament or other fluid can be infused through the guide wire and primary infusion tube 32 . Moreover, a secondary infusion tube 38 with female Luer fitting 40 can be selectively engaged with a medicament source 42 for infusing fluid from the source 42 through the secondary tube 38 .

The source 42 may be a source of magnesium sulfate source. Thus, magnesium sulfate may be infused into the patient through the catheter. The source 42 may be an IV bag. Or, the source 42 may be a syringe. Other ways known in the art to deliver magnesium sulfate may also be used that do not necessarily include using the catheter to deliver the magnesium sulfate, e.g., a syringe can be used to inject magnesium sulfate directly into the patient through the skin.

As discussed further below, the tubes 20 , 24 , 32 , 38 are held in a distally-tapered connector manifold 44 . As also set forth further below, the connector manifold 44 establishes respective pathways for fluid communication between the tubes 20 , 24 , 32 , 38 and respective lumens in a catheter body 46 .

In any case, the connector manifold 44 establishes a pathway for fluid communication between the heat exchange fluid supply tube 20 and the heat exchange fluid supply lumen of the catheter. Likewise, the connector manifold 44 establishes a pathway for fluid communication between the heat exchange fluid return tube 24 and the heat exchange fluid return lumen. Further, the connector manifold 44 establishes a pathway for fluid communication between the guide wire and primary infusion tube 32 , and the guide wire lumen, which can terminate at an open distal hole 62 defined by a distally tapered and chamfered distal tip 63 of the catheter body 46 . Also, the connector manifold 44 establishes a pathway for fluid communication between the secondary infusion tube 38 and the secondary infusion lumen, which can terminate at an infusion port 64 in a distal segment of the catheter body 46 . Additional ports can be provided along the length of the catheter.

An exemplary non-limiting catheter 18 has a distally-located heat exchange member for effecting heat exchange with the patient 11 when the catheter is positioned in the vasculature or rectum or other orifice of a patient. The heat exchange member can be any of the heat exchange members disclosed in the above-referenced patents. By way of example, a non-limiting catheter shown in FIG. 1 can have proximal and distal thin-walled heat exchange membranes 66 , 68 that are arranged along the last fifteen or so centimeters of the catheter body 46 and that are bonded to the outer surface of the catheter body 46 , with the infusion port 64 being located between the heat exchange membranes 66 , 68 . Thus, each preferred non-limiting heat exchange membrane is about six centimeters to seven and one-half centimeters in length, with the heat exchange membranes being longitudinally spaced from each other along the catheter body 46 in the preferred embodiment shown. Essentially, the heat exchange membranes 66 , 68 extend along most or all of that portion of the catheter 46 that is intubated within the patient. The heat exchange membranes can be established by a medical balloon material.

The heat exchange membranes 66 , 68 can be inflated with heat exchange fluid from the heat exchange fluid source 12 as supplied from the heat exchange fluid supply lumen, and heat exchange fluid from the heat exchange membranes 66 , 68 is returned via the heat exchange fluid return lumen to the heat exchange fluid source 12 .

If desired, a temperature sensor 70 such as a thermistor or other suitable device can be attached to the catheter 18 as shown. The sensor 70 can be mounted on the catheter 18 by solvent bonding at a point that is proximal to the membranes 66 , 68 . Or, the sensor 70 can be disposed in a lumen of the catheter 18 , or attached to a wire that is disposed in a lumen of the catheter 18 , with the sensor hanging outside the catheter 18 . Alternatively, a separate temperature probe can be used, such as the esophageal probe disclosed in U.S. Pat. No. 6,290,717, incorporated herein by reference. As yet another alternative, a rectal probe or tympanic temperature sensor can be used. In any case, the sensor is electrically connected to the heat exchange fluid source 12 for control of the temperature of the heat exchange fluid as described in various of the above-referenced patents.

As envisioned by the present invention, the structure set forth above can be used in many medical applications to cool a patient and/or to maintain temperature in a normothermic or hypothermic patient, for purposes of improving the medical outcomes of, e.g., cardiac arrest patients, patients suffering from myocardial infarction or stroke, etc. As another example, head trauma can be treated by and after lowering and maintaining the patient's temperature below normal body temperature. Preferably, particularly in the case of myocardial infarction, the heat exchange portions are advanced into the vena cava of the patient 11 to cool blood flowing to the heart.

Now referring to FIG. 2, an alternate catheter 100 can include plural heat exchange elements 102 . The heat exchange elements 102 can be established by one or more metal, preferably gold, hollow elongated segments that have external surfaces which have irregular exterior surfaces. Separating adjacent heat exchange elements 102 can be a flexible articulating joint 104 , it being understood that the heat exchange elements 102 and joints 104 can be formed from a single piece of material such as plastic or metal, e.g., gold. The details of the heat exchange elements 102 and their configuration are set forth in U.S. Pat. No. 6,096,068, incorporated herein by reference. In any case, heat exchange fluid is circulated in a closed fluid communication loop between the heat exchange elements 102 and a heater/chiller to remove heat from the patient 12 to add heat to the patient to rewarm the patient after surgery or after the termination of therapeutic hypothermia treatment. When compressed gas is used as the heat exchange fluid, the gas is directed into the catheter, where it expands to cool the catheter and, thus, the patient.

FIG. 3 shows still another alternate heat exchange catheter 200 . The catheter 200 shown in FIG. 3 can include plural heat exchange elements 202 . The heat exchange elements 202 can be established by, e.g., three heat exchange fluid return tubes made of hollow plastic or metal, with each tube establishing a respective heat exchange fluid return lumen. A central heat exchange fluid supply lumen is established by a center tube 204 . It is to be understood that the supply lumen conveys heat exchange fluid from a heater/chiller in a distal direction along the catheter 200 , whereas the heat exchange elements 202 (the heat exchange fluid return tubes) convey heat exchange fluid back to the heater/chiller in a proximal direction as indicated by the arrows 206 in FIG. 3. Thus, heat exchange fluid is circulated in a closed fluid communication loop between the heat exchange elements 202 and heater/chiller to remove heat from the patient or to add heat to the patient to rewarm the patient after surgery or after the termination of therapeutic hypothermia treatment.

The heat exchange fluid return tubes are spirally formed around the center tube 204 , and can be adhered thereto or not. That is, the preferred heat exchange elements 202 define spirals. The length “L” of the heat exchange region of the catheter 200 can be about 250 millimeters, with the pitch of the spiral heat exchange elements 202 being about 64 millimeters. In any case, the heat exchange fluid supply lumen terminates in a hollow distal tip 208 , as do the lumens of the heat exchange elements 202 . Accordingly, heat exchange fluid passes from the supply tube to the return tubes at the distal tip 208 .

In operation, any one of the above-disclosed catheters is advanced (by, e.g., emergency response personnel) into the vasculature (preferably, the inferior vena cava or superior vena cava) or other cavity such as the rectum of a patient diagnosed as requiring temperature control. For example, a patient may be diagnosed with cardiac arrest, stroke, acute MI, or other malady for which therapeutic hypothermia may be indicated.

To cool the patient, the heat exchange fluid is cooled to below body temperature and circulated through the catheter as needed to reach a desired set point. Or, if the heat exchange fluid is gas, the gas is directed into the catheter where it expands and cools, cooling the catheter body. Magnesium sulfate is infused into the patient.

FIG. 4 shows that instead of inducing hypothermia using an intravascular catheter, one or more pads 312 may be positioned against the external skin of a patient 314 (only one pad 312 shown for clarity). The pad 312 may be any one of the pads disclosed in the following U.S. patents, all of which are incorporated herein by reference: U.S. Pat. Nos. 6,827,728, 6,818,012, 6,802,855, 6,799,063, 6,764,391, 6,692,518, 6,669,715, 6,660,027, 6,648,905, 6,645,232, 6,620,187, 6,461,379, 6,375,674, 6,197,045, and 6,188,930. The temperature of the pad 312 can be controlled by a controller 316 in accordance with principles set forth in the above patents to exchange heat with the patient 314 , including to induce therapeutic mild or moderate hypothermia in the patient in response to the patient presenting with, e.g., cardiac arrest. Magnesium sulfate may then be injected into the patient prior to, during, or after inducing hypothermia in accordance with principles set forth above.

While the particular SYSTEM AND METHOD FOR TREATING CARDIAC ARREST AND MYOCARDIAL INFARCTION as herein shown and described in detail is fully capable of attaining the above-described objects of the invention, it is to be understood that it is the presently preferred embodiment of the present invention and is thus representative of the subject matter which is broadly contemplated by the present invention, that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present invention is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more”. All structural and functional equivalents to the elements of the above-described preferred embodiment that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the present claims. Moreover, it is not necessary for a device or method to address each and every problem sought to be solved by the present invention, for it to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited using the phrase “means for”.